Study of Cardioplegia in Cardiac Surgery Due to Congenital Heart Malformation in Children

A Prospective Randomized, Single-blind, Multicenter Phase II Study Comparing Two Methods of Cardioplegia in Cardiac Surgery Due to Congenital Heart Malformation in Children: Custodiol-N Versus Custodiol

The objective of this investigation is to compare the safety and cardioprotective effects of Custodiol and Custodiol-N in children undergoing cardiac surgery with cardiopulmonary bypass (CPB) due to congenital heart malformation. All endpoint timings refer to the opening of the aortic cross clamp (t=0)

Efficacy of Custodiol-N and its safety is being thoroughly studied in adults undergoing solid organ transplantation. In addition, safety data are available from its use as cardioplegic solution in approximately 400 adults. Paediatric cardiac surgery nearly exclusively addresses congenital heart disease (CHD). CHD comprises a wide variety of congenital malformations of structures of the heart or the great vessels. The causes may be genetic, environmental or both. The objective of this investigation is to compare the safety and cardioprotective effects of Custodiol and Custodiol-N in children undergoing cardiac surgery with cardiopulmonary bypass (CPB) due to congenital heart malformation.

Inclusion Criteria:

• Age from birth to less than 18 years of age
• congenital heart surgery with cardiopulmonary bypass and cardioplegia
• written informed consent of the patients and/ or their legal guardians (must be available before enrolment in the study)
• Ability of the legal guardians to understand character and individual consequences of the clinical trial

Exclusion Criteria:

• Patients who have participated within 30 days or are still participating in any other interventional study
• History of severe organic (e.g. liver or kidney) disease other than concerning the heart
• History of psychiatric disease
• Pregnancy and lactation